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Disposable Endoscopic Cutting Staplers and Reload
EUDAMEDClass IIb (EU MDR)
Ref GCERC-60F×HModel GCERC
Identity
- Trade Name
- Disposable Endoscopic Cutting Staplers and Reload EUDAMED
- Device Name
- Disposable Endoscopic Cutting Staplers and Reload EUDAMED
- Model / Reference
- GCERC EUDAMEDGCERC-60F×H EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06922798755310 EUDAMED
- Basic UDI-DI
- 692279871003L9 EUDAMED
- Direct Marketing DI
- 06922798755310 EUDAMED
- EMDN Code
- H020301040102 SINGLE PATIENT STRAIGHT LINEAR STAPLERS WITH BLADE FOR LAPAROSCOPY EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Denmark EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Sutures
Yes
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Disposable Endoscopic Cutting Staplers and Reload by Jiangsu Guanchuang Medical Technology Co., Ltd. — Class IIb — MDR — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 692279871003L9 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Jiangsu Guanchuang Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000021127
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (1)
- EUDAMED c7cbf981-8788-4aa2-a7e8-711a1889abe5 61 fields · synced Jun 19, 2026